Olympus Corporation’s Criminal Record — The DOJ Guilty Plea and What It Means for Patients

Super Lawyers® 2014–2024CALL 24/7(888) 348-2735

Olympus Scope — Infection Claims

Hospitalized With an Infection After a Scope Procedure?

If you were told it was “just a complication,” Olympus’s federal guilty plea — and $85 million in penalties — tell a different story. In two minutes, you can know whether your case qualifies.

ACTIVE LITIGATION. 250+ patients · most recent filing: June 2026 · deadlines vary by state — some as short as one year.

Were you hospitalized with an infection within 30 days of an endoscopy or scope procedure?

Yes — See If My Case Qualifiesfree · takes 2 minutes
I think so / not sure

Free · confidential · no fee unless there is a recovery · answering doesn’t commit you to anything. Court costs and litigation expenses are advanced by counsel and repaid from the recovery. You are not responsible for court costs or litigation expenses if there is no recovery, unless a court directs otherwise. The attorney’s fee is a percentage of the gross recovery, calculated before expenses are deducted.

Prefer to talk it through? (888) 348-2735 — free and confidential.

Stefanie A. Murphy & Matthew T. Marin

Partners

You’ll get a straight answer even if it’s “you don’t qualify.” Everything you share is confidential — even if you never hire us. No fee unless there is a recovery; costs are advanced and reimbursed only out of a recovery. If you do qualify, our Olympus scope litigation team requests the medical and hospital records — you don’t chase them.

Qualification depends on what the medical records show — the scope involved, the infection, and the timing. We’ll review them and give you a straight answer either way.

What Did Olympus Corporation Plead Guilty To?

On December 10, 2018, Olympus Medical Systems Corporation — the US subsidiary responsible for distributing Olympus medical devices — entered a guilty plea in the United States District Court for the District of New Jersey (Case No. 2:18-cr-00727-SRC). The corporation pleaded guilty to three counts of distributing misbranded medical devices in violation of 21 U.S.C. § 331(k), the federal statute governing misbranded devices under the Federal Food, Drug, and Cosmetic Act. Pleading alongside the corporation was Hisao Yabe, who served as a senior executive at Olympus Medical Systems Corporation during the relevant period.

Yabe personally pleaded guilty to one count. The combined penalties paid by Olympus and Yabe totaled $85 million in criminal penalties. (Source: DOJ press release, December 10, 2018, justice.gov.) Under federal law, a medical device is “misbranded” when it is labeled or marketed in a way that is false or misleading — including by omitting material information that would be required to appear in reports submitted to the FDA.

Olympus admitted that it failed to file the FDA Medical Device Reports (MDRs) about infection events and adverse outcomes that it was required by law to submit. These were the reports that should have captured the infection outbreaks occurring at US hospitals during the 2012–2015 period. The admission was explicit: Olympus knew its duodenoscopes were linked to patient infections. It knew it was required to report these events to the FDA.

It failed to report them accurately and completely. The December 2018 guilty plea is a judicial admission that cannot be relitigated in civil proceedings — and it establishes a corporate criminal record of failing to report adverse events directly relevant to every product liability lawsuit arising from Olympus scope infections.

What Did Olympus Know and When?

The criminal plea did not emerge in a vacuum. It followed years of documented corporate knowledge that Olympus’s duodenoscopes were spreading antibiotic-resistant infections across US hospitals — knowledge that Olympus chose not to communicate to the FDA, to hospitals, or to patients. The timeline of corporate knowledge, confirmed through peer-reviewed literature, Senate HELP Committee investigation, and DOJ records, is as follows:

What Does the Criminal Record Mean for Individual Lawsuits?

What Other Regulatory Actions Has Olympus Faced?

The December 2018 criminal guilty plea was not an isolated event — it is part of a pattern of regulatory non-compliance that has continued for more than a decade after the initial outbreaks. The complete Olympus regulatory record represents five major FDA enforcement actions across ten years, plus a criminal guilty plea. No medical device manufacturer in the FDA’s modern enforcement history carries a comparable record.

March 2018 — FDA Warning Letter MARCS-CMS 546986: Following the February 2015 Safety Communication, the FDA ordered Olympus to conduct mandatory postmarket surveillance of its duodenoscopes under Section 522 of the Federal Food, Drug, and Cosmetic Act. More than two years later — while simultaneously under criminal investigation — Olympus had established zero surveillance sites. The March 2018 warning letter documented this defiance.

This surveillance non-compliance occurred during the same period as the reporting failures admitted in the December 2018 guilty plea.

March 2023 — FDA Warning Letter MARCS-CMS 654013: Olympus failed to investigate cracking of the MAJ-2315 distal end cover for approximately two years after becoming aware of the defect. This is the same pattern as the reporting failure: Olympus identifies a device problem, takes no corrective action, and eventually faces regulatory consequences. (Source: van der Ploeg et al., Gut, 2024, PMID 38182137.)

December 2024 — FDA Class I Recall Z-0905-2025: The MAJ-891 Forceps/Irrigation Plug — used during ERCP procedures — was subject to Class I recall (the most serious FDA recall classification). 30,140 units in US commerce. MAUDE adverse event reports associated with this recall include 120+ reported injuries and 1 confirmed death. (Source: FDA Recall Z-0905-2025, December 18, 2024.)

June 2025 — FDA Import Alert 89-04: The FDA blocked 58 Olympus device models from entering the United States from the Aizu, Japan manufacturing facility, citing ongoing violations of 21 CFR Part 820 Quality System Regulations. An import alert authorizing customs detention of an entire company’s product line without physical examination is one of the most aggressive regulatory actions the FDA can take against a device manufacturer.

October 2025 — Urgent Field Safety Notice: Olympus admitted that prior reprocessing protocols for its current-generation TJF-Q190V, TJF-Q290V, and TJF-Q170V duodenoscopes were insufficient — and that 10X magnification tools, which hospitals had never previously been told to use, were now required to detect contamination invisible to the naked eye. The notice confirmed 2 deaths and 5 serious injuries linked to these devices.

This 2025 admission that prior protocols were inadequate — seven years after the company admitted failing to report the contamination problem in federal court — extends the evidentiary foundation across the entire claims period. (Source: Olympus Urgent Field Safety Notice, October 14–17, 2025, on file.) Five major FDA enforcement actions across a ten-year period, plus a criminal guilty plea, constitute a regulatory record with no parallel in medical device history.

For patients and their attorneys, this record provides a layered evidentiary foundation across the entire claims period. (Source: Bomman S et al., Clinical Endoscopy, January 2022, PMC8831410.)

Frequently Asked Questions About the Olympus Criminal History

Attorney Advertising. Marin & Murphy Law Firm. Prior results do not guarantee a similar outcome.

Attorney Advertising. This page is general information, not legal advice, and does not create an attorney-client relationship — that relationship is formed only by a signed written agreement. The attorneys of Marin & Murphy Law Firm are licensed in Rhode Island, South Carolina, Connecticut, and Massachusetts. We evaluate potential claims nationwide; for matters arising in states where our attorneys are not admitted, we associate with or refer to locally licensed co-counsel and do not ourselves practice law in those jurisdictions.

Submitting the contact form or contacting the firm does not create an attorney-client relationship. Representation is offered on a contingent-fee basis: no fee unless there is a recovery, though a client may be responsible for case costs and expenses. The statute of limitations may sharply limit the time to file a claim. Prior results do not guarantee a similar outcome, and no outcome is guaranteed. Responsible attorney: Matthew T.

Court costs and litigation expenses are advanced by counsel and repaid from the recovery. You are not responsible for court costs or litigation expenses if there is no recovery, unless a court directs otherwise. The attorney’s fee is a percentage of the gross recovery, calculated before expenses are deducted.

Marin, Marin & Murphy Law Firm (Rhode Island).